| October 16, 2008 |
| November 25, 2009 |
| October 2008 |
| March 2010 (final data collection date for primary outcome measure) |
| Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid [ Time Frame: day -1, 1, 29, 30, 59, 60 ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00774072 on ClinicalTrials.gov Archive Site |
| Measure of serum levels of tobramycin [ Time Frame: day 1, 30 and 60 ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization |
| Nasal Inhalation of Tobramycin by the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization in the Upper Airways |
The purpose of this study is to determine whether the nasal inhalation of Gernebcin® is effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
- Cystic Fibrosis
- Pseudomonas Aeruginosa
|
| Drug: Tobramycin (Gernebcin®) |
| |
| |
| |
| Recruiting |
| 10 |
|
| March 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- subject has a confirmed diagnosis of cystic fibrosis
- detection of P. aeruginosa in nasal lavage (culture) with chronic P.a. colonization of the lung (from day -28)
- informed consent of the patients or parents
- subject is older than 7 years
- subject is able to comply with the inhalation procedures and nasal lavage procedures scheduled in the protocol
- women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol
Exclusion Criteria:
- subject has a critical condition defined as: FEV1 < 30% and / or SaO2 < 93% without O2-substitution; need of O2-substitution
- subject had an ENT surgery within 3 months prior to study
- subject shows signs of nasal bleeding
- subject has an ear drum perforation
- subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy against pseudomonas aerug.
- subject is unlikely to comply with the procedures scheduled in the protocol
- subject has a known allergic reaction to the medication
- subject is pregnant or breastfeeding
- subject participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study.
- systemic (oral or intravenous) antibiotic treatment against P.a. 14 days prior to the inclusion and during the study
- if serum level of tobramycin is above 2 mg/l one hour after inhalation, subject has to withdraw the participation in the study.
- progressed renal insufficiency
- severe damage of the N. acusticus
- dizziness (potential damage of. N. vestibularis)
|
| Both |
| 8 Years and older |
| No |
|
|
| Germany |
| |
| NCT00774072 |
| Dr. Jochen Mainz, University of Jena, Children`s hospital |
| tobra nasal CF pilot |
| University of Jena |
|
| Study Chair: |
Jochen Mainz, M.D. |
University of Jena, Children`s hospital |
|
|
| University of Jena |
| November 2009 |
